Efficacy and Safety of FITpatch Compared to Standard Opioid Treatment in Cancer Pain (FT-015-IN)

May 4, 2012 updated by: Nycomed

A Randomised, Open, Parallel-group, Multi-centre Trial to Investigate Analgesic Efficacy and Safety of Transdermal Fentanyl (FITpatch) Compared to Standard Opioid Treatment in Cancer Pain.

Primary objectives:

  • To determine non-inferiority of FITpatch with regard to efficacy compared to standard opioid treatment
  • To assess the safety of FITpatch compared to standard opioid treatment

Secondary objectives:

  • To assess the intake of oral morphine as rescue analgesic to FITpatch compared to standard opioid treatment
  • To assess Quality of life reported with FITpatch compared to standard opioid treatment

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

220

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Subjects that have insufficiently treated, cancer-related chronic pain that requires long-term treatment with an opioid at Step 3 on the WHO Ladder, and with Karnofsky performance status above 50.

  1. Subject informed consent given.
  2. Aged between 18 and 75 years, and for female subjects a proven negative pregnancy test and adequate contraception.
  3. No significant skin lesions on relevant surfaces on the body or diffuse skin diseases.
  4. No impaired respiratory function nor neurological or psychiatric impairment.
  5. No known abuse of drug, narcotic or alcohol.
  6. Not pregnant or nursing.
  7. Not hypersensitive/allergic to fentanyl or morphine.
  8. No head injury, primary brain tumor, increased intracranial pressure or impaired consciousness.
  9. Not participating in other clinical trials.

Exclusion Criteria:

All exclusion criteria must be answered No for a patient to participate in the trial.

  1. Does the patient have significant skin lesions on the upper arms/flat surface of the upper torso or diffuse skin disease (psoriasis or eczema) that preclude application of fentanyl patches?
  2. Does the patient have a known abuse of drug, narcotic or alcohol?
  3. Is the patient pregnant or nursing?
  4. Has the patient neurological or mental impairment that may compromise data collection?
  5. Is the patient hypersensitive/allergic to fentanyl or morphine or any of the ingredients in the trial medication?
  6. Has the patient any major head injury, primary brain tumour, increased intracranial pressure or impaired consciousness?
  7. Does the patient participate in other clinical with other investigational drugs or investigation al medical devices or has been participating in such a trial for the past 30 days?

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Primary:
To determine non-inferiority of FITpatch with regard to efficacy compared to standard opioid treatment and to assess the safety of FITpatch compared to standard opioid treatment

Secondary Outcome Measures

Outcome Measure
Secondary:
To assess the intake of oral morphine as rescue analgesic to FITpatch compared to standard opioid treatment and to assess Quality of life reported with FITpatch compared to standard opioid treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nycomed

Investigators

  • Study Chair: Nycomed Clinical Project Management, Headquaters

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2004

Study Completion (Actual)

August 1, 2007

Study Registration Dates

First Submitted

December 14, 2005

First Submitted That Met QC Criteria

January 17, 2006

First Posted (Estimate)

January 19, 2006

Study Record Updates

Last Update Posted (Estimate)

May 7, 2012

Last Update Submitted That Met QC Criteria

May 4, 2012

Last Verified

May 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FT-015-IN

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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